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World Health Organisation adds three Disease Modifying Therapies for MS onto Essential Medicine List

July 27, 2023 | Treatments

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Today, the World Health Organisation (WHO) added three Disease Modifying Treatments (DMTs) for Multiple Sclerosis (MS) onto its Essential Medicines List for the first time.

Addressing the global MS movement, Prof Mai Sharawy, Chair of the Board of Trustees of Multiple Sclerosis International Federation (MSIF), highlights the positive impact of the WHO’s decision and acknowledges the efforts made by member organisations and many others.

The inclusion of three disease-modifying therapies for MS in the essential medicines list (EML) by the World Health Organization (WHO) is a momentous decision that underscores pressing health challenges faced by people with MS and their carers worldwide and especially in countries where access to disease-modifying therapies is often limited or unavailable as shown in the Atlas of MS.

This inclusion will facilitate the procurement, availability, and affordability of these medicines and ultimately improve the health outcomes and quality of life of people with MS around the world. This achievement would not have been possible without the concerted and tireless efforts of MSIF member organizations, healthcare professionals, researchers in TRIMs and neurological organizations, people with MS, and dedicated individuals who worked together as a great team committed to improving global health.

With this landmark decision, the WHO acknowledges the critical importance of making MS treatments available in all health systems at all times. It is a significant moment in the history of MS, marking a crucial step towards improving access to MS treatments for people living with MS, particularly those in low- and middle-income countries or low-resource settings, who face significant barriers to accessing MS treatments.

The three treatments added onto WHO Essential Medicines List are rituximab, cladribine and glatiramer acetate. MSIF and its members stress that the three medicines listed provide a baseline of care but are not the only ones that are effective and important for the treatment of MS. As this is the first time that MS treatments are included, a new section has been created on the list to emphasise the importance of treatments for MS.

The WHO’s Essential Medicines List is an internationally recognised set of selected medicines to help countries choose how to treat their priority health needs.  Countries frequently use the list to develop their own national lists of essential medicines.

The inclusion of MS treatments on the list sends a powerful message to governments and regulators around the world that MS treatments are safe and effective, and they should be made available to those who could benefit from them. Although these treatments represent a highly prioritised selection of the DMTs that are currently used to treat MS, this decision lays the foundations for better access to all DMTs around the world.

Effective treatments are crucial to help people with MS, slowing the accumulation of disability, reducing the number of relapses and maintaining independence. Access to a range of DMTs can help people with MS maintain economic productivity and actively contribute to society. MS is a complex disease and it is important that different DMTs are made available to suit the different needs amongst the MS population in a country.

Together with its members, MSIF has been advocating for the inclusion of MS treatments on the Essential Medicines List. The application was made with the help of two independent panels and endorsed by 15 organisations, including all regional MS research and clinical networks (TRIMS), regional neurological academies and the World Federation of Neurology.

This is a great moment for the MS community to celebrate this major step forward for all people with and affected by MS around the world and is a testament to the power of international collaboration. Peer Baneke, Chief Executive Officer of the MS International Federation said:

This decision is a major milestone for people affected by MS everywhere. We are delighted that the WHO Expert Committee has recognised the importance of including MS treatments on the Essential Medicines List. It is vital for people with MS to get the right treatment at the right time. MSIF and its member organisations around the world believe that the provision of the types of DMT represented by those on the list is the minimum for adequate MS care. Every country now needs to ensure people with MS can access a range of MS treatments at all times.

Global demand for accessible MS treatments

There is unequal access to MS treatments globally, with high efficacy treatments particularly poorly available. The main barriers for access – as identified in the Atlas of MS – are the cost of treatment to the individual, government, healthcare system, or insurance provider. There is global consensus that a range of MS treatments should be available in all health systems at all times.

MSIF and its members will now strive to work with governments, industry, healthcare providers and patient organisations around the world to make affordable access to the best available treatments and care for people affected by MS a reality.

As the global MS community unites to advocate for change, it is imperative that every country now needs to ensure people with MS can access a range of MS treatments at all times.

Read the original article from MSIF here.

Read the WHOs announcement here.

Comments from MSNZ

The recognition by the World Health Organisation (WHO) is a huge moment for many people impacted by MS globally, particularly in countries where access is limited or unavailable. New Zealand is fortunate to have Copaxone (Glatiramer Acetate) and Rituximab (under specific conditions) already available along a range of other high-efficacious therapies.

Applications for the funding of Cladribine were first made by Merck Serano in 2018. In July 2018, the Neurological Subcommittee of PTAC recommended the funding application for cladribine be declined. Following this, the supplier (Merck Serano) submitted additional information and in November 2019, PTAC recommended that cladribine should be funded only if it is cost-neutral to fingolimod.

As detailed in Pharmac’s response to our OIA in April 2021:

PHARMAC has not declined the funding application for cladribine, it remains an option for investment for PHARMAC, however it is not currently a working priority for PHARMAC. This follows the advice we received from the Pharmacology and Therapeutics Advisory Committee (PTAC) in November 2019. 

In July 2018, the Neurological Subcommittee of PTAC recommended the funding application for cladribine be declined. Following this, the supplier submitted additional information and in November 2019, PTAC recommended that cladribine should be funded only if it is cost-neutral to fingolimod.” 19 Sep 2021 | OIA Response | Information about funding for Cladribine  – Pharmac | New Zealand Government

Since then we understand there has been no further development as further funding applications have been declined as not being cost-neutral. MSNZ is currently writing to Pharmac to alert them of WHO’s recommendation and express our continued disappointment that the lack of transparent processes makes applications for ‘cost-neutral funding’ a barrier for access.